Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT)

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·Optune System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT SYSTEM ON THE RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY S

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·SPOT-LIGHT HER2 CISH KIT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front, Front Advance Cardiac Cryoablation, Freezor MAX & CryoConsoleSystem

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·CyPass Micro-Stent

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Superion Indirect Decompression System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI Quad CRT-D, Claria MRI Quad CRT-D, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP 2000 SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Sofmed Toric Weeklies

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·FlexAbility and FlexAbility SE Ablation Catheter; FlexAbility Cables, Sensor Enabled

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Prestige LP Cervical Disc – Two Level

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS